Cleared Traditional

K930299 - BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET

K930299 is an FDA 510(k) clearance for BARD BLOOD CARDIOPLEGIA HEAT EXCHANGER/..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K930299 · C.R. Bard, Inc. · Cardiovascular device
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Jun 1993
Decision
152d
Days
Class 2
Risk

K930299 is an FDA 510(k) clearance for the BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K930299

510(k) Number K930299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date June 22, 1993
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K930299.
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
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ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154 · Electromedics, Inc. · Jul 1993
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920178 · Lifestream Int'L, Inc. · May 1993
PLEUR-EVAC CARDIOTOMY RESERVOIR
K925046 · Deknatel, Inc. · Apr 1993
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
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